Patients and clinical data
A retrospective search was performed of our endoscopic database 2017–2020, using the search terms ‘Plug’ AND ‘Vacuum therapy’. Cases were selected with the following criteria:
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1.
confirmed upper—GI anastomotic or staple line leakage with a direct or drainage tube based entero-athmospheric or -cutaneous fistula,
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2.
patients were pre-treated with surgery (including vacuum therapy) and/or established endoscopic methods such as endoscopic vacuum therapy.
The study was approved by the Medical Ethical Committee Hamburg, Germany (approval number: PV3548). Informed consent was obtained from all patients before study inclusion. This retrospective study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments and the local legal regulations (HmbKHG). All relevant clinical data regarding patients and endoscopic examinations were obtained from a combination of in- and out-patient clinical and endoscopic record reviews, and communication with patients and their attending physicians. The data obtained included healing of fistula, septic complications, and therapy-related complications.
Technique of the Vac-Plug method
The principle of our method consists of a peroral endoscopic plugging of the remaining orifice of the leak with an absorbable and ingrowing plug and percutaneous treatment of the remaining fistula and abscess cavity with endoscopic open-pore film drainage therapy (Fig. 1).
(A) Anastomotic leak with a percutaneous fistula. (B) Endoscopic plug implantation into the fistula orifice. (C) Percutaneous and fistuloscopically placed under pressure therapy with open-pore film drainage. (D) Separation of the plug plate and continuation of the vacuum therapy until closure of the orifice. (E) Avoidance of premature skin closure by implantation of a shortened und inverted PEG tube. (F) Removal of the PEG and final state.
Plug preparation
The plugs applied were either Biodesign Fistula Plugs (COOK Medical, 52,499 Baesweiler Germany) with an average degradation time of 14 days (Fig. 2A) or a self-made plug based on a Vicryl mesh (Polyglactin 910) copolymer of lactide (a cyclic diester of lactic acid) and glycolide (a cyclic diester of glycolic acid, Ethicon, 22,851 Norderstedt, Germany) with a slower degradation of approximately 90 days (Fig. 2B). The mesh was cut in two parts and a base plate and a cone were fashioned and sewed with absorbable sutures (Vicryl 3,0 metrics, Ethicon, 22,851 Norderstedt, Germany).
Two different types of plugs. (A) A modified Biodesign Fistula Plug (Cook), (B) self-made plug with waterproof cap and resorbable cone by Vicryl mesh. The base plate is sealed with bone wax (*). For endoscopic implantation, a strap with an absorbable suture is sewed inside the waterproof basis plate (yellow arrow) that can be grabbed by the endoscopic forceps and one strap at the tip of the plug (red arrow).
The plugs were then further modified before implantation: the plug was covered with a thin layer of Bonewax (Ethicon, 22,851 Norderstedt, Germany), which is a mixture of vaseline and beeswax (Fig. 2A, yellow dotted line). This creates a waterproof layer on the intra-luminal base-plate of the plug and prolongs the time of absorption and destruction by enteric fluids. Without this procedure the porcine mucosa plug would be digested and destabilized in the upper GI tract within 2–3 days. For endoscopic implantation, a strap with an absorbable suture was sewn onto the inside of the waterproof base, so it could be grabbed by the endoscopic forceps. Furthermore, one strap was fixed at the tip of the plug (Vicryl 3,0 metrics, Ethicon, 22,851 Norderstedt, Germany, Fig. 2A, yellow and red arrow). A second Vicryl loop (about 75 cm long) was knotted to the strap at the tip for the pull through maneuver and later served as an external fixation to the skin so as to avoid plug dislocation on the intestinal side.
Plug insertion
First a suture is pulled through the fistula into the enteric lumen and then externalized through the mouth: Fistuloscopy is performed with a small lumen endoscope (such as GIF-XP190N, Olympus Corp., Tokyo, Japan) and a guide wire (Jagwire; Boston Scientific, Natick, MA) is placed through the leakage or through a drain, if still in place. Via peroral endoscopy, the end of the guide wire is grasped with a snare or forceps and externalized. Over the guide wire, an endoscopic retrograde cholangiopancreatography catheter is introduced and the guide wire replaced. A thick monofilament suture (e.g. PDS 1,0 metrics, Ethicon, 22,851 Norderstedt, Germany) is pushed through the whole length of this catheter. The catheter is then removed and the suture is provisionally fixed to the skin and outside the mouth. At this time drainages can be removed. Endoscopic flushing and debridement of the fistula is performed. In some cases, an endoscopic fistula brush might help in the process (Fistula Brush PR, OVESCO, Tuebingen, Germany).
If the fine caliber endoscope cannot be pushed through the orifice, a dilation with a balloon catheter is performed. Another option is to omit the fistuloscopic exploration and to introduce of a thick monofilament suture (e.g. PDS 1,0 metrics, Ethicon, 22,851 Norderstedt, Germany) via the drainage to pull it with an endoscopic forceps through the orifice. The second strap on the tip is connected with the transoral suture and the plug is now endoscopically pulled through to the intestinal orifice (leakage) (Fig. 3A,B) with a forceps (Fig. 3C). After exact positioning of the plug, the long strap knotted to the suture at the tip of the plug is fixed to the skin to prevent intraluminal dislocation of the plug. The external loop can be removed 10 days after plug implantation with only little risk of dislocation.
(A) The loop at the base plate of the plug is grasped. (B) By careful pulling of the suture that is fixated at the tip of the plug and is externalized through the fistula to the skin, (C) the plug is placed at the enteric fistula orifice under endoscopic vison.
Percutaneous suction therapy
Depending on the size and the depth of the fistula, an open pore film drainage is used to stimulate the ingrowth of the plug by suction and evacuation of secretions and debris. Also, it reduces the size of the defect by formation of granulation tissue.
A small diameter catheter (Fig. 4A, yellow arrows) covered with an open pore film (Suprasorb-CNP, Lohmann & Rauscher, 56,579 Rengsdorf, Germany, Fig. 4A) is inserted into the distal fistula tract between the tip of the plug and the skin, and continuous suction is applied using an electric pump (ActiV.A.C, setting: – 125 mmHg, continuous negative pressure, high intensity; KCI, San Antonio, Texas, USA—Fig. 4B). This procedure too, is performed using a guide wire, with the tip placed close to the end of the plug (Fig. 4C,D). The distance between the skin and the plug should be measured with a small caliber flexible endoscope beforehand. Avoiding a dislocation, the tube is stitched on the skin (Fig. 4E).
(A) A small diameter catheter prepared with several side- (yellow arrows) and end whole (blue arrow) is covered with a segment of open-pore film (red arrow, Suprasorb-CNP, Lohmann & Rauscher, 56,579 Rengsdorf, Germany). (B) Open-pore film drainages in (12 Charrière, 4 cm length). (C) The tip (*) of a guide wire is placed on the ground of the fistula tract. (D) After fistuloscopic measurement of the length with a small caliber endoscope, the open-pore film drainage is placed inside and externally fixed with sutures (E). Fistuloscopic image after plugging and 10 days of open-pore film therapy. The tip of the plug (*) is still visible but seems to be ingrowth. (F) In case of a long fistula tract, a PEG is inserted in the fistula/abscess for daily rinsing (G). After fistuloscopic control, the PEG can be further shortened or removed (H).
Changing process
Exchange of the suction material can safely be performed every 3–7 days over a guide wire under fistuloscopic and endoscopic control with the small diameter endoscope (Fig. 4F). Compared to the sponge, the open-pore film drainage allows a longer duration of suction (up to seven days) since the ingrowth is reduced and the film is not as fragile as the sponge. Status of closure, granulation and contamination should be evaluated during endoscopy. Also, the degradation process of the plug should be monitored.
The fistula tract is rinsed, remaining necrosis, leftovers or foreign bodies are removed. The size and length of the newly placed open-pore film drainage should be adapted to the decreasing size of the fistula/abscess.
Percutaneous suction therapy should be stopped when the tract between the plug and the skin is short enough for spontaneous healing and closure of the intestinal orifice is reached. In cases of a long remaining fistula tract, we placed in some cases a shortened PEG tube with the gastral plate placed at the skin into the remaining tract for daily rinsing to avoid a to early closure of the skin with the risk of a recurrent abscess (Fig. 4G). After further wound healing, the PEG tube can be shortened or later omitted (Fig. 4H).
Statistical analysis
Due to the exploratory nature of this pilot series, no comparative data were analyzed. All statistical analyses were carried out using IBM SPSS Statistics for Mac (Version 20, IBM Corporation, Armonk, New York, USA). The median and range were used to describe the results.
